You want to bring diabetes care to the next level?
We are looking for a Clinical Projects Specialist.
The mission of Inreda is to bring a high quality, reliable and affordable fully closed-loop bi-hormonal artificial pancreas system to the home of all people with diabetes who are in need of such a solution. To achieve this, we do everything to bring costs down to lower barriers and increase access for all. In this way, we contribute to the improvement of diabetes treatment and the patient’s quality of life. Eventually, this will result in reduced societal costs and a reduced risk of complications.
Inreda is looking for a Clinical Projects Specialist who will prepare, coordinate/conduct and report clinical projects associated with our artificial pancreas (medical device, class IIb). Current and upcoming clinical projects include clinical studies for CE-marking, clinical evaluation, post-market clinical follow up and new product development and testing. You will be part of the Clinical Projects Department, which currently exists of three people and works in close collaboration with R&D, Marketing Sales & Service and Quality.
- Develop and review study designs, protocols and key clinical study documents.
- Coordinate and conduct clinical studies.
- Perform data analysis and interpretation of clinical data.
- Prepare and review study and clinical evaluation reports.
- Perform comprehensive literature search to support clinical projects, stay informed of state-of-the art concerning diabetes technology.
- Set up and maintain communication with external parties, such as study centers and CROs.
- Provide clinical guidance and expert input from technical medical perspective to R&D regarding new product development.
- A minimum of a Bachelor’s Degree in a relevant medical or life sciences field (such as (Technical) Medicine, Biomedical Sciences, Life Sciences & Technology, Biomedical Engineering) or an equivalent combination of education and experience.
- Experience in clinical research, medical device research experience highly desired.
- Knowledge of regulation, standards and guidance for healthcare/clinical research/medical devices (GCP and ISO 14155 certificates are a preference).
- Strong written, verbal and communication skills in Dutch and English.
- Strong interpersonal and analytical skills, detail oriented.
- Proficient with MS Office programs, Matlab, SPSS, R and/or comparable programs.
- Affinity with diabetes (technology) is a preference.
We are passionate to develop innovations that are focused on improving the glucose time in range for people with diabetes and minimizing the impact of the disease in their daily lives.
- People are the centre and starting point of all we do.
- We understand what is needed to improve quality of life for people with diabetes and we will not stop before we bring that solution to the market.
- We operate in a way that our solutions become available to those who need it most. Social responsibility is a key driver.
- We do this by dreaming big.
- We always ask ourselves “why not” instead of “cannot”.
- We have our own way and that makes us what we are.
- We do everything to be transparent to all stakeholders.
- We realize that our products are a main element in the wellbeing of people with diabetes. Therefore, being reliable and providing excellent service at all times is our first priority.
Please send an e-mail to firstname.lastname@example.org
If you have questions regarding this application, please call +31 (0) 547 262628 and ask for Helga Blauw.
Note: Agency calls aren’t that appreciated.
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